We represent pharmacists who serve as patient care providers in acute and. This innovative video program is an ideal competency assessment and training tool for everyone concerned with safety and quality issues related to sterile compounding. Our team has also worked closely with pharmacy stars to develop an easytouse web application that supports ongoing sterile compounding compliance and selfauditing. Blueprint for implementing usp chapter 797 for compounding sterile. In response to an increasing number of patient injuries due to. Blueprint for implementing usp chapter 797 for compounding sterile preparations. Usp posts revised pdfs for usp 795, 797, 800, 825 updated november 2019. The revision bulletin to usp chapter, pharmaceutical. Denver, co, june 25, 2007 at the annual ashp summer meeting and exhibition, baxa corporation is promoting the benefits of specialty pharmacy software, usp 797 compliance training. This course outlines general design aspects of changes, the intent of the standard, facility. The ashp discussion guide on usp chapter compounding. Strategies for ensuring compliance with revised usp chapter. Finding products that comply with usp mandates isnt always easy, but it is essential.
Introduction competency only no ce pre2019 based on the popular ashp training video and workbook, this first course in a three course series introduces the learner to. Ensuring safe sterile compounding practices through education. In addition, the ashps discussion guides for both the original and revised chapters provide a. Hazardous drug safety and compliance with usp chapter in the health system. Denver, co, june 25, 2007 at the annual ashp summer meeting and exhibition, baxa corporation is promoting the benefits of specialty pharmacy software, usp 797 compliance training and. Overall, pharmacies response to achieve compliance with these changes may. Regardless of the regulatory status, compliance with all usp compounding chapters in their current or official versions is. Ashp guidelines on compounding sterile preparations american. This is done through the use of our marketing automation software, web chat software, use of web analytics, cookies, web beacons, server logs analysis tools profiling, and the use targeting cookies to. This is an updated management level course geared towards individuals who are responsible for ensuring. Ashp s video guide to chapter 797 provides a concise overview of the essential components of the revised and updated chapter. Partnering with pharmacists to ensure compliance with usp chapters, 797, and guidance is an evolving advanced pharmacy technician role. Learn about how to properly clean and disinfect critical pharmacy surfaces with contec healthcares usp 797 guidelines overview.
Challenges of medication management in nuclear medicine, amerinet. The new usp 795, 797, and 800 regulations are creating real challenges for hospital pharmacies in these areas, and edge has a wide variety of solutions, such as mitomycin bladder instillation kits for usp. Both ismp and ashp recommended providing iv push medications in a. Usp chapter 797 will become the official standard and will be published in the second supplement to usp 31nf 26 and in the pharmacists pharmacopeia. While the intent of the standards has not changed, the revision includes important additions and clarifica. While the implementation date of the new usp general chapter sterile compounding has been postponed, it is not too early to start preparing. Blueprint for implementing usp chapter 797 for compounding. Strategies for ensuring compliance by the december 2019 deadline. Some state regulations require full compliance with usp chapter 797, some have. Usp 797 usp 800 pharmacy design compliance youtube. Such software systems are involved in sterile compounding to achieve and maintain a state of control and compliance. Ismp guidelines for safe preparation of compounded sterile.
Pharmacopeia, ashp, the state boards of pharmacy and the fda are all working in unison to forever change the standards by which your pharmacy compounds sterile preparations. Adapted from the ashp discussion guide on usp chapter for. This discussion guide is intended to assist healthsystem pharmacists with. Sterile preparations, became effective january 1, 2004. Iv workflow management systems wmss and robotic compounding.
Attendees were surveyed prior to the summit to gather information about their. Where can i find updated usp 800, 797, and other compounding documentation. Currently, 20 states require compliance with usp chapter. In the ashp discussion guide for compounding sterile preparations, developed by the american society of healthsystem pharmacists ashp and baxter healthcare, several activities were identified as. D uring the 1960s, the practice of pharmacy began growing and evolving. The center was purposebuilt to support training in aseptic technique, pharmacy workflow and practice, cleanroom design and maintenance and usp 797 compliance among other topics. D assistant director sterile products may 2, 2017 oshp annual meeting.
What is the most critical issue to address in the quest for usp compliance. For most health systems, transforming the organizations culture concerning safe hd. Ashp summer meeting and exhibition in boston xtract allergy. This fully updated version offers a complete 60 minute overview of the requirements and correct procedures as described in usp chapter, compounding sterile preparations. Strategies for ensuring compliance with revised usp chapter 797. A triad of free assistance is now available, all via the compounding today website a completely revised usp preparation checklist. Data from these tools were published annually from 2011 through. Baxa corporation features pharmacy training programs. This month, we talked with many attendees who stopped by the tsi booth at the american society of healthsystem pharmacists ashp summer meeting. As frontline staff, pharmacy technicians have the unique opportunity to be at the forefront of leading process changes to ensure safe medication practices.
Hazardous drug compounding pharmacy technician toolkit. How software can help you follow usp 797 guidelines. Compounding sterile preparations competency library view product. What is usp 797 and how software can keep you compliant. These include proposed revisions to usp chapter, the creation of usp. One of the most important factors for compliance with usp 797 is a reliable system to track its many facets. Key compliance criteria for usp general chapter 797. At this location, you may register for and access the criticalpoint usp 797 and 800 electronic gap tools. List the facility and monitoring elements for compliance with usp prioritize. Washington law holds the responsible manager and all pharmacists on duty responsible for ensuring pharmacy compliance.
The recently published usp chapter, pharmaceutical compounding. Kienle is director of accreditation and medication safety for cardinal health innovative delivery solutions. Usp 800 standards upgrading a usp 797 cleanroom for. To download the complimentary usp general chapter pharmaceutical compounding sterile preparations, please click here. Associations healthcare facilities accreditation program, and dnv. Usp and coverage for many other types of health care entities. Prweb june 25, 2007 at the annual ashp summer meeting and exhibition, baxa corporation is promoting the benefits of specialty pharmacy software, usp 797. Kienle is also the author of companion guide to compounding sterile preparations. Ashps visual guide to chapter video and companion guide. While usp suspended the december 2019 implementation date for revised usp chapter pharmaceutical compoundingsterile preparations, dont. Blueprint for implementing chapter 797 for compounding.
Compounding sterile preparations american society of. Zellmer served nearly 40 years on the staff of the american society of healthsystem pharmacists ashp in various capacities. Ashp taking steps to address drug manufacturing quality and national security risks. This course provides a better understanding of the upcoming revision to usp 797 and new usp 800.
Ashp provides several guidelines for safe compounding practices28,31,32 and a discussion guide on usp chapter 797 17 and has recognized usp chapter 797 as a relevant practice standard in the ashp guidelines. The immediateuse provision allows for the preparation and dispensing of compounded sterile products csps without the need to be in compliance with usp requirements such as iso class 5 hood. One of the best ways to ensure usp 797 control and compliance is to utilize a webbased usp 797 qualitymanagement system that offers staff. Ashps sterile product preparation certificate program teaches the advanced skills. Regulatory aspects of compliance with usp, fda northeast region. Usp and niosh guidance in the face of the compounding tragedy, ashp midyear. In the ashp discussion guide for compounding sterile preparations, developed by the american society of healthsystem pharmacists ashp and baxter healthcare, several activities. Subscribing to ashps compounding sterile preparations competency library allows your institution to evaluate compounding personnel knowledge regarding compounding sterile preparations, and. Pharmacists, pharmacy technicians, and other individuals who are practicing andor. Practical compliance with usp chapters and course description and target audience.
The safety of your patients begins by ensuring that you understand the practice requirements set forth in usp chapter. Strategies for ensuring compliance with revised usp. Usp chapters and through the use of tools and best practice recommendations. One of the best ways to ensure usp 797 control and compliance is to utilize a webbased usp 797 qualitymanagement system that offers staff selfpaced online learning, including interactive courses, video scenarios, and testing.